Reported Nov 21, 2018 · Terminated

VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro…

Luminex Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Luminex Corporation · 12212 Technology Blvd · Austin, TX · 78727-6101

Is this the product you have?

  • VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged
  • as five-pack carriers) Product UsageIn vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria
Lot codes and dates
  • Supplier raw tray lots 195916-070518
  • and 190943-073118 Utility Tray Lots
    • 082518018C
    • 081618018C
    • 082918018C
    • 090418018B
    • 081118018C and 082718018B
Amount recalled
12,700 trays

Where it was sold

Why it was recalled

Potential to lead to a false negative results.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 28, 2021 · Data as of Sep 19, 5:34 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.